BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL, CHECKPOINT, STERILE

    MDR report key: 6075251 · Received November 3, 2016

    Report

    Report Number
    3005985723-2016-00351
    Event Type
    Injury
    Date Received
    November 3, 2016
    Date of Event
    October 28, 2016
    Report Date
    January 5, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K141989
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: THE SURGEON WAS UNABLE TO LOCATE THE CHECKPOINT INSERTED INTO THE PELVIS. THE CHECKPOINT INSERTED INTO THE PELVIS WAS THE TIBIAL CHECKPOINT AND NOT THE PELVIC CHECKPOINT. THE SURGEON USED X-RAY TO LOCATE THE CHECKPOINT AND REMOVED IT. THERE WAS A DELAY OF 50 MINUTES TOTAL. DEVICE EVALUATION AND RESULTS: THE CHECKPOINT WAS NOT RETURNED. THE ISSUE IN THIS COMPLAINT WAS NOT A PRODUCT DEFECT BUT AN ISSUE LOCATING THE DEVICE AFTER USE. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE COMPETED AS THE LOT NUMBER WAS NOT REPORTED. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN (B)(6) RELATED TO P/N 111651 SHOWS ONE ADDITIONAL COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION FOR THIS SPECIFIC PART NUMBER IN THA CASES. THIS COMPLAINT IS (B)(4). CONCLUSIONS: THE SURGEON USED A CHECKPOINT THAT WAS NOT CALLED OUT IN THE USER GUIDE AND HAD DIFFICULTY WITH THE CHECKPOINT REMOVAL. THE CHECKPOINT HAD NO DEFICIENCY. THERE IS NO ADDITIONAL INVESTIGATION REQUIRED. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE PROCEDURE, THE SURGEON WAS UNABLE TO LOCATE THE CHECKPOINT IN THE PELVIS. THE SURGEON USED A 111651 TIBIAL CHECKPOINT INSTEAD OF THE SUGGESTED 116230 CHECKPOINT 3.5MM HEX 15MM. AN INTRA-OPERATIVE X-RAY WAS DONE AND ALLOWED HIM TO LOCATE AND REMOVE THE CHECKPOINT. THE TOTAL CASE DELAY WAS 50 MINUTES.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE PROCEDURE, THE SURGEON WAS UNABLE TO LOCATE THE CHECKPOINT IN THE PELVIS. THE SURGEON USED A 111651 TIBIAL CHECKPOINT INSTEAD OF THE SUGGESTED 116230 CHECKPOINT 3.5MM HEX 15MM. AN INTRA-OPERATIVE X-RAY WAS DONE AND ALLOWED HIM TO LOCATE AND REMOVE THE CHECKPOINT. THE TOTAL CASE DELAY WAS 50 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728186 TIBIAL, CHECKPOINT, STERILE STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other